Medical tube and medical tube assembly

ABSTRACT

A medical tube is disclosed, which can include a main body in which a distal portion of a tubular proximal separable piece is detachably connected to a proximal portion of a tubular distal separable piece; and a state maintaining mechanism for maintaining a connected state of the distal separable piece and the proximal separable piece. In addition, the main body is inserted into a body starting from the distal separable piece side, and is disposed inside the body in a state in which a distal end and a proximal end thereof are exposed outside of the body. In addition, the state maintaining mechanism can include a string which is disposed inside the main body and interlocks the distal separable piece and the proximal separable piece, and the connected state can be released by cutting the string.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/JP2013/059897 filed on Apr. 1, 2013, the entire content of which isincorporated herein by reference.

TECHNICAL FIELD

The present disclosure generally relates to a medical tube and a medicaltube assembly.

BACKGROUND DISCUSSION

If a person suffers from a urinary incontinence, for example, if aperson suffers from a stress urinary incontinence, then urine leakagecan be caused by application of abdominal pressure during normalexercise or by laughing, coughing, or sneezing. The cause of this maybe, for example, that the pelvic floor muscle which is a muscle forsupporting the urethra is loosened by birth.

For the treatment of urinary incontinence, a surgical treatment iseffective, in which there is used, for example, a belt-shaped implantcalled “sling.” The sling is indwelled inside the body and the urethrais supported by the sling (see, for example, U.S. Patent ApplicationPublication No. 2003/171644. In order to indwell the sling inside thebody, an operator would incise the vagina with a surgical knife, dissectthe part between the urethra and vagina, and make the dissected regionand the outside communicate with each other through obturator foramensby use of a puncture needle or the like. Then, in this state, the slingis indwelled into the body.

If the vaginal wall is incised once, however, a situation may occur thatthe sling is exposed to the inside of the vagina from a wound caused bythe incision of the vaginal wall, and complications may be caused by aninfection from the wound. Further, since the vaginal wall is incised,there is such a defect that the invasion is great and the burden on thepatient is heavy. Further, the urethra may be damaged by a surgicalknife in the course of the procedure by the operator. In addition, thefingertip of the operator himself/herself may be damaged or injured bythe surgical knife.

SUMMARY

A medical tube and a medical tube assembly are disclosed which can beeasily dawn out of a living body.

A medical tube is disclosed to be used in introducing into a living bodya belt-shaped elongated article for treatment of a pelvic organ, themedical tube including a main body in which a distal portion of atubular proximal separable piece is detachably connected to a proximalportion of a tubular distal separable piece and a state maintainingmechanism maintaining a connected state of the distal separable pieceand the proximal separable piece, characterized in that the main body isinserted into the body starting from the distal separable piece side,and is disposed inside the body in a state in which a distal end and aproximal end thereof are exposed outside of the body.

The medical tube as disclosed, wherein the state maintaining mechanismhas an interlock member, which is disposed in the main body andinterlocks the distal separable piece and the proximal separable piece.

The medical tube as disclosed, wherein the main body has a sectioncurved in a circular arc shape.

The medical tube as disclosed, wherein the main body which is tubular inshape has an internal space so configured that the belt-shaped elongatedarticle can be inserted therein and passed therethrough.

The medical tube as disclosed, characterized in that the main body has aflat shape as a cross-sectional shape at least at a central portion in alongitudinal direction thereof.

The medical tube as disclosed, wherein the connected state is releasedby cutting the interlock member.

The medical tube as disclosed, wherein the interlock member interlocksthe proximal portion of the distal separable piece and a proximalportion of the proximal separable piece.

The medical tube as disclosed, wherein the distal portion of theproximal separable piece is inserted in the proximal portion of thedistal separable piece, whereby the distal separable piece and theproximal separable piece are connected.

A medical tube is disclosed, which can include a tubular main bodyhaving a curved section and provided with an internal space in which abelt-shaped elongated article for treatment of urinary incontinence canbe inserted, characterized in that the main body has a configuration inwhich a distal portion of a tubular proximal separable piece isdetachably connected to a proximal portion of a tubular distal separablepiece.

A medical tube assembly comprising the medical tube as disclosed and aurethral-insertion section which can be inserted into a urethra, whereinin a state in which the main body is disposed inside the body, thecentral portion is located between the urethral-insertion section and avagina, and a major axis direction of the central portion issubstantially parallel to the urethral-insertion section.

A medical tube assembly is disclosed, which comprises the medical tubeas disclosed and an elongated insertion section which is inserted intothe main body, characterized in that the medical tube assembly is usedin a state in which the insertion section is inserted into the mainbody.

At the time of embedding a sling into a living body, a sheath (medicaltube) can be used suitably. For example, the sheath is inserted into apuncture hole, establishing a state where both ends of the sheath areprotruded outside of the living body. Next, the sling is inserted intothe sheath, followed by drawing only the sheath out of the living body,leaving the sling inside the living body. As a result, the sling isembedded inside the living body. However, it has been difficult to drawthe elongated sheath out of the living body while leaving the slinginside the living body.

A method is disclosed of introducing a belt-shaped elongated article fortreatment of a pelvic organ into a living body with a medical tube, themedical tube having a main body in which a distal portion of a tubularproximal separable piece is detachably connected to a proximal portionof a tubular distal separable piece and a state maintaining mechanismmaintaining a connected state of the distal separable piece and theproximal separable piece, the method comprising: inserting the main bodyof the medical tube into the living body starting from the distalseparable piece side; and disposing the main body of the medical tubeinside the living body in a state in which a distal end and a proximalend of the main body are exposed outside of the living body.

According to the present disclosure, the state maintaining mechanism isprovided and, therefore, the main body can be disposed inside a bodywhile maintaining the connected state of the distal separable piece andthe proximal separable piece. Consequently, the main body can bedisposed into the body smoothly. At the time of drawing the main bodyout of the body, In accordance with an exemplary embodiment, the statemaintaining mechanism is released, whereby the distal separable piececan be drawn out from the distal side, and the proximal separable piececan be drawn out from the proximal side. In this way, by drawing out themain body through dividing the main body into two pieces, the main bodycan be drawn out of the body easily. In addition, the main body can bedrawn out of the body while maintaining the posture of the implantdisposed inside the main body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view showing a puncture device to which amedical tube (medical tube assembly) according to a first embodiment ofthe present disclosure is applied.

FIG. 2 is a side view of the puncture device shown in FIG. 1.

FIG. 3 is a plan view showing an operating member possessed by thepuncture device shown in FIG. 1.

FIG. 4(a) is a perspective view of a puncture member possessed by thepuncture device shown in FIG. 1.

FIG. 4(b) is a sectional view taken along line IXb-IXb of FIG. 4(a).

FIG. 5 is a sectional view of the puncture member shown in FIG. 4(a).

FIG. 6(a) is a top plan view of a state maintaining mechanism possessedby the puncture member shown in FIG. 4(a).

FIGS. 6(b) and 6(c) are sectional views of a state maintaining mechanismpossessed by the puncture member shown in FIG. 4(a).

FIGS. 7(a)-7(c) show a partial enlarged view depicting a statemaintaining mechanism possessed by the puncture member shown in FIG. 3,wherein FIGS. 7(a) and 7(b) are each plan views showing modifications,and FIG. 7(c) is a plan view showing the present embodiment.

FIGS. 8(a) and 8(b) illustrate a second anchor possessed by the puncturedevice shown in FIG. 1, wherein FIG. 8(a) is a sectional view, and FIG.8(b) is a sectional view showing a condition where the second anchor isengaged with the puncture member.

FIGS. 9(a) and 9(b) illustrate a first anchor possessed by the puncturedevice shown in FIG. 1, wherein FIG. 9(a) is a sectional view, and FIG.9(b) is a sectional view showing a condition where the first anchor isengaged with the puncture member.

FIG. 10 is a sectional view showing a guide section of a frame possessedby the puncture device shown in FIG. 1.

FIG. 11 is a sectional view showing the guide section of the framepossessed by the puncture device shown in FIG. 1.

FIG. 12 is a sectional view showing the guide section of the framepossessed by the puncture device shown in FIG. 1.

FIG. 13 is a plan view showing a fixing section of the frame possessedby the puncture device shown in FIG. 1.

FIG. 14 is a side view of an insertion tool possessed by the puncturedevice shown in FIG. 1.

FIGS. 15(a) and 15(b) illustrate a positional relation of the puncturemember and an obturator foramen (pelvis), wherein FIG. 15(a) is a sideview and FIG. 15(b) is a front view.

FIG. 16 is a partial enlarged view of a vaginal-insertion memberpossessed by the insertion tool shown in FIG. 14.

FIG. 17(a) is a sectional view showing an example of the shape of avaginal wall.

FIG. 17(b) is a sectional view showing a state where a vaginal-insertionsection is inserted in a vagina shown in FIG. 17(a).

FIG. 18 illustrates an implant to be used with the puncture device shownin FIG. 1.

FIGS. 19(a) and 19(b) are each views for explaining an operatingprocedure of the puncture device shown in FIG. 1.

FIGS. 20(a) and 20(b) are views for explaining the operating procedureof the puncture device shown in FIG. 1.

FIG. 21 is a side view showing the relation between the puncture deviceand the pelvis at the time of the state shown in FIG. 20(a).

FIGS. 22(a) and 22(b) are each views for explaining the operatingprocedure of the puncture device shown in FIG. 1.

FIG. 23 is a side view showing the relation between the puncture deviceand the pelvis at the time of the state shown in FIG. 22(a).

FIG. 24 is a sectional view showing the posture of the puncture memberrelative to a urethra at the time of the state shown in FIG. 22(b).

FIGS. 25(a) and 25(b) are each views for explaining the operatingprocedure of the puncture device shown in FIG. 1.

FIGS. 26(a) and 26(b) are each views for explaining the operatingprocedure of the puncture device shown in FIG. 1.

FIG. 27 is a perspective view showing a medical tube (medical tubeassembly) according to a second embodiment of the present disclosure.

FIG. 28 is a sectional view showing a modification of the medical tube(medical tube assembly) shown in FIG. 27.

FIG. 29 is a perspective view showing a medical tube (medical tubeassembly) according to a third embodiment of the present disclosure.

FIG. 30 is a perspective view showing a medical tube (medical tubeassembly) according to a fourth embodiment of the present disclosure.

FIG. 31 is a perspective view showing a medical tube (medical tubeassembly) according to a fifth embodiment of the present disclosure.

FIG. 32 is a sectional view showing a medical tube (medical tubeassembly) according to a sixth embodiment of the present disclosure.

FIGS. 33(a)-33(c) illustrate a medical tube (medical tube assembly)according to a seventh embodiment of the present disclosure, whereinFIG. 33(a) is a plan view, and FIG. 33(b) and FIG. 33(c) are eachsectional views.

FIG. 34 is a sectional view showing a medical tube (medical tubeassembly) according to an eighth embodiment of the present disclosure.

FIG. 35 is a sectional view showing a modification of the medical tubeshown in FIG. 34.

FIGS. 36(a)-36(c) illustrate a medical tube (medical tube assembly)according to a ninth embodiment of the present disclosure, wherein FIG.36(a) is a plan view, and FIGS. 36(b) and 36(c) are each sectionalviews.

DETAILED DESCRIPTION

A medical tube and a medical tube assembly of the present disclosurewill be described in detail below, on the basis of preferred embodimentsillustrated in the attached drawings.

Note that in the following, for convenience of explanation, the leftside in FIG. 2 will be referred to as “distal end,” the right side as“proximal end,” the upper side as “up,” and the lower side as “down.”FIG. 2 shows a puncture device in the state of not yet used, and thisstate will be referred to as the “initial state” for convenience ofexplanation. In accordance with an exemplary embodiment, a state wherethe puncture device (insertion tool) shown in FIG. 2 is mounted onto apatient will be referred to also as the “mounted state.” Further, ineach of FIGS. 5 and 6, a puncture member extending in a circular arcshape is depicted in the state of being stretched rectilinearly, forconvenience of explanation.

First, a puncture device to which a medical tube and a medical tubeassembly of the present disclosure are applied will be described.

A puncture device 1 shown in FIGS. 1 and 2 is a device for use intreatment of female urinary incontinence, for example, in embedding(implanting) in a living body a biological tissue supporting indwellingarticle for treatment of urinary incontinence.

This puncture device 1 can include a frame (support section) 2, apuncture member 3, a urethral-insertion member 4, a vaginal-insertionmember 5, an operating member 7 and anchors 81 and 82. The puncturemember 3, the urethral-insertion member 4, the vaginal-insertion member5, the operating member 7, and the anchors 81 and 82 are each supportedby the frame 2. In accordance with an exemplary embodiment, in thepuncture device 1, the urethral-insertion member 4 and thevaginal-insertion member 5 constitute an insertion tool 6. These will besequentially described below.

The operating member 7 is a member for operating the puncture member 3.As shown in FIGS. 1 to 3, such an operating member 7 can include aninsertion section 71, a shaft section 73, and an interlock section 72interlocking the insertion section 71 and the shaft section 73. Theinsertion member 71, the interlock section 72 and the shaft section 73may be formed to be integral with one another, or, alternatively, atleast one of them may be formed as a separate body from the others ofthem.

The insertion section 71 is a part to be inserted into the puncturemember 3, and functions as a stylet for reinforcing the puncture member3 internally. With the insertion section 71 inserted in the puncturemember 3, the puncture member 3 is connected to the operating member 7,whereby an operation of the puncture member 3 by the operating member 7is enabled. The insertion member 71 as above has a circular arc shapecorresponding to the shape of the puncture member 3. The center angle ofthe insertion member 71 is set in accordance with the center angle ofthe puncture member 3. A distal portion 711 of the insertion section 71is tapered off. With the tapered-off distal portion 711 provided, theinsertion of the puncture member 3 into the insertion section 71 can beperformed smoothly.

The shaft section 73 extends along an axis J1 which intersects thecenter O of the insertion section 71 and is orthogonal to a plane f1containing the insertion section 71.

The interlock section 72 interlocks a proximal portion of the insertionsection 71 and a distal portion of the shaft section 73. The interlocksection 72 has a substantially L-shaped form of being bent substantiallyat right angle at an intermediate portion thereof. The interlock section72 functions also as a grip section to be gripped by an operator at thetime of operating the operating member 7.

The operating member 7 as above is configured to be higher in rigiditythan the puncture member 3 (main body 31). The material constituting theoperating member 7 is not particularly limited; there can be used, forexample, various metallic materials such as stainless steel, aluminum oraluminum alloys, titanium or titanium alloys.

The puncture member 3 is a member for puncturing a living body. As shownin FIG. 4(a), such a puncture member 3 can include an elongated sheath(medical tube) 30, and a needle body 35 provided at the distal end ofthe sheath 30. The sheath 30 can include the main body 31 which istubular in shape, and a state maintaining mechanism 34.

The main body 31 can include an elongated tubular body (tube), openingat both the distal end and the proximal end thereof. Such a main body 31has an internal space in which an implant main body (belt-shapedelongated article) 91 can be inserted. The main body 31 has a bent shapeof being bent in a circular arc shape, and is flat shaped in crosssection as shown in FIG. 4(b). For example, the cross-sectional shape ata central portion S4 in the longitudinal direction of the main body 31is a flat shape including a minor axis J31 and a major axis J32. As willbe described later, the implant main body 91 is disposed inside the mainbody 31. With the main body 31 flat shaped, therefore, the posture ofthe implant main body 91 within the main body 31 can be controlled. Inaddition, the width of the internal space of the main body 31 isdesigned to be substantially the same as the width of a main bodysection 911 (described later) of the implant main body 91, which canhelp ensure that even when the implant main body 91 is moved, thefrictional resistance with the internal space of the main body 31 islow, so that no unnecessary force is exerted on the implant main body91, and the main body section 911 can be disposed in a sufficientlydeveloped state within the main body 31.

Note that the flat shape of the main body 31 is not specificallyrestricted; for example, ellipses, convex lens-like shapes in section,rhombuses with corners rounded, rectangles (flat shapes) with cornersrounded, and spindle-like shapes with a central portion enlarged(enlarged in diameter) as compared with both end portions may be adoptedas the flat shape.

In the following, for convenience of explanation, an end portion locatedon the inner side in the major axis direction will be referred to alsoas an “inner circumferential portion A1,” an end portion located on theouter side will be referred to also as an “outer circumferential portionA2,” a surface oriented toward the upper side will be referred to alsoas a “front surface A3,” and a surface oriented toward the lower sidewill be referred to also as a “back surface A4,” as shown in FIG. 4(b).

As shown in FIG. 4(b), let a plane containing both the center point ofthe circular arc of the central portion S4 and the center point of thecross-sectional shape with respect to the longitudinal direction of themain body 31 (a plane containing the center axis of the main body 31) bea plane f9, and let the angle formed between the plane f9 and the minoraxis J31 at the central portion S4 be an inclination angle θ1, then theinclination angle θ1 is preferably an acute angle. With the inclinationangle θ1 set to be an acute angle, an implant 9 (described later) can bedisposed substantially in parallel to the urethra, so that the urethracan be supported more effectively. This effect will be described indetail later. Note that the inclination angle θ1 is not particularlylimited so long as it is an acute angle. In accordance with an exemplaryembodiment, for example, the inclination angle θ1 is about 20° to 60°,more preferably 30° to 45°, and further preferably about 35° to 40°.

While it is preferable that the inclination angle θ1 satisfies theaforementioned numerical range over the whole region in the extendingdirection of the main body 31, the above-mentioned effect can beexhibited if the aforementioned numerical range is satisfied at least atthe central portion S4 in the extending direction of the main body 31.Note that the “central portion S4” means a region including the partlocated between the urethra and the vagina at least in a state where aliving body is punctured by the puncture member 3 (a state where themain body 31 is disposed inside the living body). In accordance thisexemplary embodiment, it can be also said that a central portion (thecenter and the vicinity on both sides of the same) between the anchors81 and 82, in a state where the anchors 81 and 82 are in engagement withthe puncture member 33 as will be described later, is the centralportion S4.

Note that both end portions of the main body 31 may be provided withmarkers at parts which are located equidistantly from the centralportion S4 and which protrude to the outside of a living body in a statewhere the main body 31 is disposed in the living body (the state shownin FIG. 22), which can help ensure that the position of the centralportion S4 inside the living body can be confirmed by comparing thepositions of both the markers.

The configuration of the main body 31 can be described in other words asfollows. It can be also said that as shown in FIG. 4(b), the main body31 is so formed that the major axis J32 is inclined against the centeraxis J5 of the circular arc and that the center axis J5 of the circulararc and an extension line J32′ of the major axis J32 have anintersection P. In this case, the angle θ5 formed between the centeraxis J5 and the extension line J32′ is equal to the inclination angleθ1. In still other words, it can be also said that as shown in FIG. 10,in plan view as viewed from the direction of the center axis J5 of themain body 31, the main body 31 has the inner circumferential portion A1located at its inner circumferential edge and having a minimum radius ofcurvature r1 and the outer circumferential portion A2 located at itsouter circumferential edge and having a maximum radius of curvature r2,and, as shown in FIG. 4(b), the inner circumferential portion A1 and theouter circumferential portion A2 are located to be spaced from eachother in the direction of the center axis J5.

Such a main body 31 is composed of two separable pieces so that it canbe divided at an intermediate portion thereof. In accordance with anexemplary embodiment, the main body 31 is divided into a distalseparable piece 32 and a proximal separable piece 33. The distalseparable piece 32 and the proximal separable piece 33 are substantiallythe same in length, and the boundary between the two separable pieces islocated in the central portion S4.

As shown in FIG. 5, the distal separable piece 32 is tubular in shape,and has a distal-side opening 321 and a proximal-side opening 322. Inaddition, the proximal separable piece 33 is tubular in shape, and has adistal-side opening 331 and a proximal-side opening 332. A distalportion of the proximal separable piece 33 is inserted in a proximalportion of the distal separable piece 32, whereby the distal separablepiece 32 and the proximal separable piece 33 are connected with eachother. With the proximal separable piece 33 thus inserted in the distalseparable piece 32, a step which could be generated at the boundarybetween the separable pieces 32 and 33 is unlikely to be caught on thebiological tissue, so that puncture of a living body by the puncturemember 3 can be performed smoothly. Note that contrary to thisembodiment, the distal separable piece 32 may be inserted in theproximal separable piece 33 to thereby connect the separable pieces 32and 33 together.

The connected state in which these separable pieces 32 and 33 areconnected together is maintained by the state maintaining mechanism 34.As shown in FIG. 6(a), the state maintaining mechanism 34 can includeholes 342 a, 342 b and 342 c; an endless string (interlock member) 341inserted in and passed through the holes 342 a, 342 b and 342 c,exposure holes (through-holes) 345 and 346 for exposure of the string341, and a slit 347 interconnecting the exposure holes 345 and 346.

The hole 342 a is provided in a proximal portion of the proximalseparable piece 33 at a position near the inner circumferential portionA1 of the front surface A3. In accordance with an exemplary embodiment,the holes 342 b and 342 c are provided in a proximal portion of thedistal separable piece 32, oppositely at positions which are in thefront surface A3 and the back surface A4 and which are near the innercircumferential portion A1.

The string 341 is disposed inside the main body 31, while being exposedoutside of the main body 31 between the holes 342 b and 342 c andbetween the hole 342 a and the proximal-side opening 332. With thestring 341 laid around in this manner, the connected state of theseparable pieces 32 and 33 can be maintained assuredly. In addition, thedegree of exposure of the string 341 outside of the main body 31 can belowered, so that the string 341 is less liable to be caught on thebiological tissue. In accordance with an exemplary embodiment, theoverall length of the string 341 can be made as short as possible, whileenabling the string 341 to be cut as will be described later. Therefore,the string 341 is less liable to be caught on the implant main body 91at the time of inserting and passing the implant main body 91 into andthrough the main body 31. Further, since the holes 342 a, 342 b and 342c are disposed near the inner circumferential portion A1 asaforementioned, the string 341 is also disposed near the innercircumferential portion A1. Therefore, the string 341 is less likely tobe caught on the implant main body 91 at the time of inserting theimplant main body 91 into the main body 31.

The string 341 as above can be obtained, for example, by a methodwherein a string having ends is prepared, one end of the string isinserted into the main body 31 via the proximal-side opening 332, isdrawn out to the outside of the main body 31 through the hole 342 b, isinserted into the main body 31 via the hole 342 c, is drawn out to theoutside of the main body 31 through the hole 342 a, and, finally, istied with the other end of the string in the vicinity of theproximal-side opening 332. It is to be noted, however, that the positionof the knot is not limited.

Here, as shown in FIG. 6(c), the axis of the hole 342 a is inclined sothat the outside opening is located on the proximal side as comparedwith the inside opening. In accordance with an exemplary embodiment, asshown in FIG. 6(b), the axis of each of the holes 342 b and 342 c isinclined so that the outside opening is located on the distal side ascompared with the inside opening, which can help ensure that each of theholes 342 a, 342 b and 342 c can be extended along the path of thestring 341, so that the string 341 is less liable to be caught on eachof the holes 342 a, 342 b and 342 c.

The exposure holes 345 and 346 are oppositely provided in the frontsurface A3 and the back surface A4 of the proximal portion of theproximal separable piece 33. The part where the exposure holes 345 and346 are provided protrudes from a body surface in a state where the mainbody 31 is disposed inside a living body. In addition, the exposureholes 345 and 346 are located on the path of the string 341. Therefore,the string 341 is exposed outside of the main body 31 via the exposureholes 345 and 346. In accordance with an exemplary embodiment, theseexposure holes 345 and 346 are interconnected by the slit 347 providedin the inner circumferential portion A1 along the circumferentialdirection of the main body 31.

In the state maintaining mechanism 34 as above, cutting the string 341results in a state in which the distal separable piece 32 and theproximal separable piece 33 are separable from each other. Thisconfiguration can help enable the distal separable piece 32 and theproximal separable piece 33 to be put into a separable state through asimple operation. In addition, since the cutting of the string 341 isvisible, it can be relatively easily confirmed that the distal separablepiece 32 and the proximal separable piece 33 have been put into theseparable state.

With the exposure holes 345 and 346 and the slit 347 provided as in thisembodiment, the string 341 can be cut relatively easily. Referring toone example, scissors including a pair of blades (a first blade and asecond blade) are prepared, the first blade is inserted into and passedthrough the exposure holes 345 and 346, and the string 341 is positionedbetween the pair of blades. Then, the scissors are put into a closingoperation, whereby at least one of the first and second blades is passedthrough the slit 347, and the first and second blades come to overlapwith each other, in which process the string 341 is cut. Thus, where theexposure holes 345 and 346 and the slit 347 are provided, the string 341can be cut relatively easily.

As above-mentioned, in this embodiment, the slit 347 is provided, andthe slit 347 is used as a path along which the blade passes, which canhelp prevent the main body 31 from being deformed under a tension on thestring 341. For example, as shown in FIG. 7(a), the path along which theblade is passed may be composed of a hole 348 instead of the slit 347.In this case, however, depending on the hardness of the main body 31 orthe like there may arise a situation where as shown in FIG. 7(b), thehole 348 may be crushed through buckling under the tension on the string341, resulting in deformation of the main body 31. In the case of theslit 347, for example, since parts 347 a and 347 b on both sides of theslit 347 abut on and are pressed against each other, as shown in FIG.7(c), such a deformation as above-mentioned would not occur, so that themain body 31 is prevented from deformation.

In accordance with an exemplary embodiment, as shown in FIG. 5, the mainbody 31 is provided in a distal portion thereof with a pair of engagingholes 315 and 316 for engagement with the anchor 81. In accordance withan exemplary embodiment, the main body 31 is provided in a proximalportion thereof with a pair of engaging holes 317 and 318 for engagementwith the anchor 82. Out of the four engaging holes, the engaging holes315 and 317 are provided in the inner circumferential portion A1,whereas the engaging holes 316 and 318 are provided in the outercircumferential portion A2.

As aforementioned, the main body 31 is flat shaped and is less liable tobe crushed in the major axis direction, so that the spacing between theinner circumferential portion A1 and the outer circumferential portionA2 is unlikely to vary. In addition, the inner circumferential portionA1 and the outer circumferential portion A3 are larger in curvature and,hence, less susceptible to deformation, as compared with the frontsurface A3 and the back surface A4. With the engaging holes 315 and 317provided in the inner circumferential portion A1 and with the engagingholes 316 and 318 provided in the outer circumferential portion A2,therefore, the engagement between the anchors 81 and 82 and the mainbody 31 is unlikely to be released.

In addition, the spacing between the engaging holes 315 and 316 and thecentral portion S4 and the spacing between the engaging holes 317 and318 and the central portion S4 are approximately equal, which can helpensure that the anchors 81 and 82 serve as markers, whereby the positionof the central portion S4 of the main body 31 inside a living body canbe easily grasped.

The main body 31 as above is provided at the distal end thereof with theneedle body 35. As depicted in FIG. 5, the needle body 35 can include aneedle tip 351 which is tapered off, and a proximal section 352 providedon the proximal side of the needle tip 351. The proximal section 352 isinserted in the main body 31, whereby the needle body 35 is detachablyretained on the main body 31. Note that the proximal section 352 isfitted in the main body 31 with such a force that the needle body 35 canbe prevented from being unintentionally detached from the main body 31.Note that the needle body 35 may be configured to be integral with themain body 31.

The proximal section 352 is provided with an engaging section 353 forengagement with the distal portion 711 of the insertion section 71. Theengaging section 353 can include a recess, and, in an inserted statewhere the puncture member 3 is inserted in the insertion section 71, thedistal portion 711 is located inside the engaging section 353. With theengaging section 353 provided, displacement of the needle body 35relative to the insertion section 71 is restrained, and puncture of aliving body by the puncture member 3 can be performed relativelysmoothly.

The puncture member 3 has thus been described above. The center angle θ4(see FIG. 10) of the puncture member 3 is not particularly limited, andis appropriately set according to various conditions. As will bedescribed later, the center angle θ4 is so set that the needle body 35can enter a patient's body via an inguinal region on one side of thepatient, pass between the urethra and the vagina, and exit the body viaan inguinal region on the other side. In accordance with an exemplaryembodiment, for example, the center angle θ4 is preferably 150° to 270°,more preferably 170° to 250°, and further preferably 190° to 230°.

The materials constituting the main body 31 and the needle body 35 arepreferably rigid materials such as to maintain the shape of the puncturemember 3 and the internal space in a state where the puncture member 3is inserted in a living body. Examples of such rigid materialsapplicable here include, for example, various resin materials such aspolyethylene, polyimides, polyamides, polyester elastomers,polypropylene, and various metallic materials such as stainless steel,aluminum or aluminum alloys, titanium or titanium alloys. Note that themain body 31 and the needle body 35 may not necessarily be configured byadopting rigid materials, but may be configured by adopting othermaterials than rigid materials; in the latter case, the wall may bereinforced with a reinforcement member. For example, a braiding withhigh strength may be embedded in the wall, whereby the shape and theinternal space can be maintained in the state where the puncture member3 is inserted in a living body. Another example of the reinforcementmember is a spiral body, which is embedded in the wall of the main body31, whereby flexibility can be ensured while the internal space isretained to such an extent that an inserted article can be slid therein.

The main body 31 is preferably light-transmitting so that the insidethereof can be visually checked externally. This makes it possible, forexample, to check whether the distal portion 711 of the insertionsection 71 inserted to the inside is in engagement with the engagingsection 353, whether the string 341 has not been cut, and so on.

The aforementioned puncture member 3 (main body 31) and the insertionsection 71 which is inserted into the main body 31 constitute a medicaltube assembly 10; use of the puncture device 1 is started with thesemembers being in the state of the medical tube assembly 10.

Note that the number and layout of the holes (342 a, 342 b and 342 c)through which to pass the string 341 are not particularly limitedinsofar as the connected state of the distal separable piece 32 and theproximal separable piece 33 can be maintained by the string 341. Thestring 341 may not necessarily be endless, but may have ends,specifically, one end and the other end. For example, a string havingends may be prepared, one end of the string may be passed through thehole 342 a and the proximal-side opening 332 to form a loop, and theother end may be passed through the holes 342 b and 342 c to form aloop. The string 341 can include cords, belts and the like which can beused similarly to the string 341.

As shown in FIG. 8(a), the anchor (second anchor) 81 can include a basesection 811 having an insertion hole 812 in and through which the mainbody 31 is inserted and passed, and a pair of claw sections 813 and 814projecting from the base section 811 and engaging with the pair ofengaging holes 315 and 316. The cross-sectional shape of the insertionhole 812 corresponds to the cross-sectional shape of the main body 31.In a state where the puncture member 3 is inserted in and passed throughthe insertion hole 812, therefore, rotation of the anchor 81 relative tothe puncture member 3 is restrained, and the positional relation betweenthese members is maintained appropriately. When the puncture member 3 isinserted into the insertion hole 812 and the puncture member 3 is pushedforward in relation to the anchor 81, the claw sections 813 and 814 areengaged with the engaging holes 315 and 316, as shown in FIG. 8(b). As aresult, the anchor 81 is engaged with the distal separable piece 32. Inthe engaged state, the base section 811 is located on the proximal sideas compared with the claw sections 813 and 814. As aforementioned,rotation of the anchor 81 relative to the puncture member 3 isrestrained in the state where the puncture member 3 is inserted in andpassed through the insertion hole 812, and, accordingly, the engagementbetween the claw sections 813 and 814 and the engaging holes 315 and 316can be developed assuredly.

Similarly, as shown in FIG. 9(a), the anchor (first anchor) 82 caninclude a base section 821 having an insertion hole 822 in and throughwhich the main body 31 is inserted and passed, and a pair of clawsections 823 and 824 projecting from the base section 821 and engagingwith the pair of engaging holes 317 and 318. The cross-sectional shapeof the insertion hole 822 corresponds to the cross-sectional shape ofthe main body 31. In a state where the puncture member 3 is inserted inand passed through the insertion hole 822, therefore, rotation of theanchor 82 relative to the puncture member 3 is restrained, and thepositional relation between these members is maintained appropriately.When the puncture member 3 is inserted into the insertion hole 812 andthe puncture member 3 is pushed forward in relation to the anchor 82,therefore, the claw sections 823 and 824 are engaged with the engagingholes 317 and 318, as depicted in FIG. 9(b). As a result, the anchor 82is engaged with the proximal separable piece 33. As aforementioned,rotation of the anchor 82 relative to the puncture member 3 isrestrained in the state where the puncture member 3 is inserted in andpassed through the insertion hole 822, and, accordingly, engagementbetween the claw sections 823 and 824 and the engaging holes 317 and 318can be developed relatively assuredly.

The materials constituting the anchors 81 and 82 are not particularlylimited; for example, various resin materials can be used.

The frame 2 retains the operating member 7 with the puncture member 3mounted thereto so that the operating member 7 is turnable, and fixesthe insertion tool 6 and the anchors 81 and 82 in an attachable anddetachable manner. The frame 2 has a function of determining a puncturepath of the needle body 35 when the puncture member 3 punctures thebiological tissue. In accordance with an exemplary embodiment, forexample, the frame 2 can determine the positional relations of thepuncture member 3, the urethral-insertion member 4 and thevaginal-insertion member 5 so that the needle body 35 passes between theurethral-insertion member 4 and the vaginal-insertion member 5 withoutcolliding against any of these insertion members when the puncturemember 3 punctures the biological tissue.

As shown in FIGS. 1 and 2, the frame 2 can include a bearing section 21for bearing the shaft section 73 of the operating member 7; a guidesection (retaining section) 22 for guiding the puncture member 3 andretaining the first and second anchors 82 and 81 in an attachable anddetachable manner; an interlock section 23 interlocking the bearingsection 21 and the guide section 22; and a fixing section 24 to whichthe insertion tool 6 is fixed.

The bearing section 21 is located on the proximal side of the puncturedevice 1, and extends in a direction substantially orthogonal to theaxis J1. The bearing section 21 is formed with a through-hole 211 on theaxis J1, and the shaft section 73 is turnably inserted in thethrough-hole 211. As a result, the operating member 7 is supported onthe frame 2 so as to be turnable about the axis J1.

The guide section 22 is located on the distal side of the puncturedevice 1, and is disposed opposite to the bearing section 21. As shownin FIG. 10, the guide section 22 is formed therein with a roughlyC-shaped guide groove 221 for accommodating the puncture member 3 andguiding the puncture member 3. In accordance with an exemplaryembodiment, as shown in FIG. 11, in a state of being disposed within theguide groove 221, the puncture member 3 has its back surface A4 locatedon the distal side and has its front surface A3 located on the proximalside.

In addition, the guide section 22 retains the anchors 81 and 82 in anattachable and detachable manner. The anchor 82 is retained to face thedistal-side opening 222 so that the insertion hole 822 and the guidegroove 221 are continuous with each other. The anchor 81 is retained toface the proximal-side opening 223 of the guide groove 221 so that theinsertion hole 812 and the guide groove 221 are continuous with eachother.

In the initial state, the main body 31 is inserted in and passed throughthe insertion hole 822 of the anchor 82, and the needle body 35 isprotruding from the guide section 22. When the operating member 7 isrotated, the puncture member 3 gradually protrudes from the guidesection 22, and, finally, the needle body 35 enters into the guidesection 22 via the proximal-side opening 223, as shown in FIG. 12. Inthis process, on the distal side of the puncture member 3, the puncturemember 3 is passed through the insertion hole 812 of the anchor 81, andthe claw sections 813 and 814 are engaged with the engaging holes 315and 316. In accordance with an exemplary embodiment, on the proximalside of the puncture member 3, the claw sections 823 and 824 are engagedwith the engaging holes 317 and 318. As a result, the anchors 81 and 82are engaged with the puncture member 3.

Here, in this embodiment, the claw sections 813 and 814 of the anchor 81are inclined toward the forward side with respect to the movingdirection of the puncture member 3. Therefore, at the time of insertionof the puncture member 3 into the anchor 81, the claw sections 813 and814 and the puncture member 3 are prevented from being caught on eachother, and the puncture member 3 can be moved smoothly between the clawsections 813 and 814 while making sliding contact with them. It is to benoted, however, that the orientation of the anchor 82 is notparticularly limited, and the claw sections 813 and 814 may be orientedtoward the rearward side with respect to the moving direction of thepuncture member 3, reversely to this embodiment.

The interlock section 23 interlocks the bearing section 21 and the guidesection 22. In accordance with an exemplary embodiment, the interlocksection 23 has a rod-like shape extending substantially in parallel tothe axis J1. The interlock section 23 can function also as a gripsection, and an operator can use the puncture device 1 by gripping theinterlock section 23.

The fixing section 24 is disposed opposite to the interlock section 23,with the axis J1 interposed therebetween. The fixing section 24 isprovided with a recess 243 in which to fit a support section 60(described later) of the insertion tool 6, and a male screw 244. Withthe support section 60 fitted into the recess 243 and with the malescrew 244 fastened into a female screw (not illustrated) of the supportsection 60, the insertion tool 6 can be fixed to the fixing section 24.

As illustrated in FIGS. 1 and 14, the insertion tool 6 can include aurethral-insertion section (second insertion section) 41 to be insertedinto a urethra, a vaginal-insertion section (first insertion section) 51to be inserted into a vagina, and the support section 60 supporting theurethral-insertion section 41 and the vaginal-insertion section 51. Asaforementioned, the insertion tool 6 can include the urethral-insertionmember 4 and the vaginal-insertion member 5, wherein theurethral-insertion member 4 has the urethral-insertion section 41, andthe vaginal-insertion member 5 has the vaginal-insertion section 51. Thesupport section 60 can include a support section 40 which is possessedby the urethral-insertion member 4 and which supports theurethral-insertion section 41; and a support section 50, which ispossessed by the vaginal-insertion member 5 and which supports thevaginal-insertion section 51. In the insertion tool 6, theurethral-insertion member 4 and the vaginal-insertion member 5 can beattached to and detached from each other through the support sections 40and 50. The urethral-insertion member 4 and the vaginal-insertion member5 will be sequentially described below.

The urethral-insertion member 4 can include the urethral-insertionsection 41, which is elongated and which, from its distal end to itsintermediate portion, is to be inserted into the urethra, and thesupport section 40 supporting the urethral-insertion section 41. Notethat in the following, for convenience of explanation, the part locatedinside the urethra (inclusive of the bladder) in the mounted state willbe referred to also as the “insertion section 411,” whereas the partexposed from the urethral orifice to the outside of the body in themounted state will be referred to also as the “non-insertion section412.”

The urethral-insertion section 41 has a straight tubular shape with thedistal end rounded. The insertion section 411 is provided at a distalportion thereof with an expandable and contractible balloon 42, and aurine drain section 47. The balloon 42 can function as a restrictingsection, which restricts the position in the axial direction of theurethral-insertion member 4 within the urethra. In accordance with anexemplary embodiment, at the time of using the puncture device 1, theballoon 42 is expanded after inserted into a patient's bladder. Then,the expanded balloon 42 is caught on a bladder neck, whereby theposition of the urethral-insertion member 4 relative to the bladder andthe urethra is fixed. In accordance with an exemplary embodiment, theurine drain section 47 is used for draining urine present in thebladder.

The balloon 42 is connected to a balloon port 43 provided at a proximalportion of the urethral-insertion section 41, through the inside of theurethral-insertion section 41. A balloon expanding device such as asyringe can be connected to the balloon port 43. The balloon 42 isexpanded when a working fluid (a liquid such as physiological saline, ora gas or the like) is supplied from the balloon expanding device intothe balloon 42. On the contrary, the balloon 42 is contracted when theworking fluid is drawn out of the balloon 42 by the balloon expandingdevice. Note that in FIG. 14, the contracted state of the balloon 42 isindicated by alternate long and two short dashes line, and the expandedstate of the balloon 42 is indicated by solid line.

In accordance with an exemplary embodiment, the urine drain section 47is provided with a drain hole 471 through which the inside and theoutside of the urine drain section 47 communicate with each other. Theurine drain section 47 is connected to a urine drain port 48 provided ata proximal portion of the urethral-insertion section 41, through theinside of the urethral-insertion section 41. Therefore, urine introducedvia the drain hole 471 can be drained via the urine drain port 48.

The balloon 42 and the urine drain section 47 can be configured, forexample, by a double lumen.

The insertion section 411 is formed at an intermediate portion thereofwith a plurality of suction holes 44. In accordance with an exemplaryembodiment, the plurality of suction holes 44 are disposed over thewhole circumferential range of the urethral-insertion section 41. Eachof the suction holes 44 is connected to a suction port 45 provided at aproximal portion of the urethral-insertion section 41, through theurethral-insertion section 41. A suction device such as a pump can beconnected to the suction port 45. When the suction device is operated ina state where the urethral-insertion section 41 is inserted in theurethra, a urethral wall can be secured by suction onto theurethral-insertion section 41. When in this condition theurethral-insertion section 41 is pushed in toward the distal side (intothe living body), the urethra is also pushed in as a result, whereby,for example, the bladder can be shifted to such a position as not tooverlap with a puncture path for the puncture member 3, and thereby, thepuncture path for the puncture member 3 can be secured. Accordingly,puncture by the puncture member 3 can be performed relatively accuratelyand safely. Note that the number of the suction holes 44 is notparticularly limited; for example, only one suction hole may beprovided. In accordance with an exemplary embodiment, the layout of thesuction holes 44 is not specifically restricted; for example, thesuction holes 44 may be formed in only part in the circumferentialdirection of the urethral-insertion section 41.

At the boundary between the insertion section 411 and the non-insertionsection 412, there is provided a marker 46 for confirming the depth ofinsertion of the urethral-insertion section 41 into the urethra. Themarker 46 is located at the urethral orifice when the urethral-insertionsection 41 is inserted in the urethra and the balloon 42 is locatedinside the bladder. As a result, the depth of insertion of the insertionsection 411 into the urethra can be easily confirmed. It is sufficientfor the marker 46 to be visibly checkable externally; thus, the marker46 may be configured, for example, as a colored part, a rugged part orthe like. Note that graduations indicative of the distance from thedistal end of the urethral-insertion section 41 may be provided in placeof the marker 46.

The length of the insertion section 411 is not particularly limited, andmay be appropriately set according to the length of the patient'surethra, the shape of the patient's bladder, etc. In view of that thelength of a female urethra is generally about 30 to 50 mm, it ispreferred that the length of the insertion section 411 is about 50 to100 mm.

The length of the non-insertion section 412 (the spacing between theurethral orifice and the support section 40) is not specificallyrestricted, and is preferably not more than about 100 mm, morepreferably in the range of about 20 to 50 mm. By this, the non-insertionsection 412 can be made to have a suitable length, and operability isenhanced. If the length of the non-insertion section 412 exceeds theabove-mentioned upper limit, there may arise, depending on theconfiguration of the frame 2 or the like, a situation in which thecenter of gravity of the puncture device 1 is largely spaced from thepatient and, accordingly, the stability of the puncture device 1 in themounted state is lowered.

The material constituting the urethral-insertion member 4 is notparticularly limited. For example, various metallic materials such asstainless steel, aluminum or aluminum alloys, titanium or titaniumalloys, etc. and various resin materials can be used.

Here, for example, the inclination angle θ2 of the plane f9 (plane f1)against the plane f2 orthogonal to the axis J2 of the urethral-insertionsection 41 is preferably about 20° to 60°, more preferably about 30° to45°, and further preferably about 35° to 40°. In accordance with anexemplary embodiment, the main body 31 is preferably so set indwellingin a living body that the angle formed between the plane f9 and theplane orthogonal to the axis of the urethra is about 20° to 60°, morepreferably so set indwelling in the living body that the angle is about30° to 45°, and further preferably so set indwelling in the living bodythat the angle if about 35° to 40°, which can help ensure that punctureby the puncture member 3 can be performed relatively easily, and thepuncture distance in puncture by the puncture member 3 can be madeshorter.

Describing more specifically, with the inclination angle θ2 set withinthe above-mentioned range, the puncture member 3 can capture left andright obturator foramens 1101 and 1102 of a pelvis 1100 wider on aplanar basis, as depicted in FIG. 15(a), and a wide puncture space forthe puncture member 3 can be secured. In accordance with an exemplaryembodiment, in a state where a patient is set in a predeterminedposition (lithotomy position), the puncture member 3 can be made topuncture in a direction comparatively nearer to a perpendiculardirection relative to the obturator foramens 1101 and 1102. Therefore,the puncture by the puncture member 3 can be carried out relativelyeasily. In addition, where the puncture member 3 is made to puncture ina direction comparatively nearer to the perpendicular direction relativeto the obturator foramens 1101 and 1102, the needle body 35 of thepuncture member 3 passes a shallow portion of the tissue, so that theneedle body 35 of the puncture member 3 can pass between the left andright obturator foramens 1101 and 1102 while taking a shorter course.Therefore, as shown in FIG. 15(b), the puncture member 3 can be made topass those zones in the obturator foramens 1101 and 1102, which are neara pubic symphysis 1200, preferably, safety zones S5. Since the safetyzones S5 are parts where there are few nerves and blood vessels, whichshould be prevented from being damaged, the puncture can be performed bythe puncture member 3 relatively safely. Accordingly, a less invasiveprocedure can be realized, and the burden on the patient can be reduced.Thus, with the inclination angle θ2 set within the above-mentionedrange, the puncture of the patient by the puncture member 3 can beperformed more suitably. In addition, the puncture at the aforementionedangle makes it easier to aim at the tissue between a middle-part urethra(which refers to a middle part in the longitudinal direction of theurethra) and the vagina. The position between the middle-part urethraand the vagina is a position suitable as a part where to performtreatment of urinary incontinence by embedding the implant 9.

In accordance with an exemplary embodiment, where the inclination angleθ2 is below the above-mentioned lower limit or above the above-mentionedupper limit, there may arise, depending on individual differencesconcerning the patient or the posture of the patient during theprocedure or the like, a situation where the puncture member 3 cannotcapture the obturator foramens 1101 and 1102 wide on a planar basis orwhere the puncture path cannot be made sufficiently short.

More preferably, for example, the puncture is conducted in a state wherethe urethra or the vagina or both the urethra and the vagina arepositionally shifted in the manner of being pushed in toward the innerside of the body, whereby a region between the middle-part urethra andthe vagina can be punctured relatively easily. The method for pushing ineither one of the urethra and the vagina toward the inner side of thebody can, for example, by a method wherein the urethral-insertion member4 and/or the vaginal-insertion member 5 is inserted into a suitableposition, then, in this condition, the urethra and/or the vagina isattracted by suction by the suction holes 44 and 59 (described later)provided in these insertion members, and thereafter theurethral-insertion member 4 and/or the vaginal-insertion member 5 ismoved further toward the inner side of the body along the axis thereofto a predetermined position. Where the puncture is conducted by settingthe main body 31 perpendicularly relative to the left and rightobturator foramens 1101 and 1102 of the pelvis in the state where atleast one of the urethra and the vagina has thus been positionallyshifted in the manner of being pushed in toward the inner side of thebody, a passage can be formed in a position suitable for indwelling ofthe implant 9.

It can be preferable to form the passage by adopting a setting such thatthe trajectory of the main body 31 passes the safety zones S5 in theleft and right obturator foramens 1101 and 1102 of the pelvis, shiftingat least one of the urethra and the vagina toward the inner side of thebody so that the trajectory is positioned between the middle-parturethra and the vagina, and performing the puncture by the main body 31along the trajectory.

As shown in FIGS. 1 and 14, the vaginal-insertion member 5 can includethe vaginal-insertion section (first insertion section) 51 which iselongated and which, from its distal end to its intermediate portion, isto be inserted in the vagina; and the support section 50 which supportsthe vaginal-insertion section 51. Note that in the following, forconvenience of explanation, the part located inside the vagina in themounted state will be referred to also as the “insertion section 511,”whereas the part which is exposed from the vaginal orifice to theoutside of the body in the mounted state and which ranges to the supportsection 50 will be referred to also as the “non-insertion section 512.”

The insertion section 511 is elongated in shape. The insertion section511 extends while being inclined against the insertion section 411 so asto be spaced away from the insertion section 411 on the distal side.With the insertion section 511 inclined against the insertion section411, the positional relation between the insertion sections 411 and 511can be made closer to the positional relation between the urethra andthe vagina, as compared with the case where the insertion section 511 isnot inclined. Therefore, in the mounted state, the puncture device 1 canbe held onto the patient more stably, and the burden on the patient canbe alleviated. The inclination angle θ3 of the insertion section 511against the insertion angle 411 is not particularly limited; forexample, the inclination angle θ3 is preferably about 0° to 45°, morepreferably about 0° to 30°, which helps enable the above-mentionedeffects to be exhibited. In accordance with an exemplary embodiment, ifthe inclination angle θ3 is below the above-mentioned lower limit orabove the above-mentioned upper limit, there may arise, depending onindividual differences concerning the patient or the posture of thepatient during the procedure, a situation in which the vagina or theurethra is unnaturally deformed in the mounted state, and the puncturedevice 1 is not held stably.

As shown in FIG. 16, the insertion section 511 has a flat shape crushedin the vertical direction of the puncture device 1 (in the direction inwhich the urethra and the vagina are arrayed). In accordance with anexemplary embodiment, the insertion section 511 can include a centralportion which is substantially constant in width, and a distal portionwhich is somewhat rounded. The length L2 of the insertion section 511 isnot particularly limited, and is preferably about 20 to 100 mm, morepreferably about 30 to 60 mm. In accordance with an exemplaryembodiment, the width W1 of the insertion section 511 is notspecifically restricted, and is preferably about 10 to 40 mm, morepreferably about 20 to 30 mm. Further, the thickness of the insertionsection 511 is not particularly limited, and is preferably about 5 to 25mm, more preferably about 10 to 20 mm. With the length, width andthickness set in these ranges, the insertion section 511 is made to havea shape and a size suited to general vaginas. Accordingly, the stabilityof the puncture device 1 in the mounted state is increased, and theburden on the patient can be reduced.

An upper surface (a surface on the urethral-insertion section 41 side)511 a of the insertion section 511 is formed with a plurality ofbottomed recesses 53. Note that the number of the recesses 53 is notparticularly limited, and, for example, only one recess may be provided.At a bottom surface of each recess 53, there is provided a singlesuction hole 59. Each suction hole 59 is connected to a suction port 54provided at a proximal portion of the insertion section 511, by way ofthe inside of the insertion section 511. The suction port 54 is soprovided as to be located outside the living body in the mounted state.A suction device such as a pump can be connected to the suction port 54.When the suction device is operated in a state where the insertionsection 511 is inserted in the vagina, a vaginal anterior wall which isan upper surface of the vaginal wall is secured by suction onto theinsertion section 511. When the vaginal-insertion section 51 is pushedin toward the distal side (into the body) with the vaginal wall thusfixed by suction, the vaginal wall can be pushed in as a result.Therefore, the disposition and shape of the vaginal wall can beconditioned, a puncture path for the puncture member 3 can be secured,and puncture by the puncture member 3 can be carried out relativelyaccurately and safely.

The region S2 where the plurality of recesses 53 are formed is disposedopposite to a region S1. The needle tip of the puncture member 3 passesbetween these regions S1 and S2. Since a urethral posterior wall (whichis a lower surface of the urethral wall) is suction held onto theinsertion section 411 in the region S1 as described before and thevaginal anterior wall is suction held onto the insertion section 511 inthe region S2, the urethral wall and the vaginal wall are spaced widerapart from each other between the regions S1 and S2. Therefore, bypassing the puncture member 3 through such a region, the puncture by thepuncture member 3 can be performed relatively safely.

The region S2 stretches over substantially the whole range in the widthdirection of the upper surface 511 a. The width W2 of the region S2 isnot particularly limited, and is preferably about 9 to 39 mm, morepreferably about 19 to 29 mm, which can help enable the vaginal anteriorwall to be suction held onto the insertion section 511 more reliably,without being considerably influenced by the shape of the vaginal wall.For example, a patient may have a vagina 1400 shaped as shown in FIG.17(a), wherein part of a vaginal anterior wall 1410 droops down into theinside of the vagina. Even in such a case, setting the width W2 asabove-mentioned helps ensure that as shown in FIG. 17(b), not only thedrooping-down part but also the parts on both sides of the drooping-downpart can be suction held reliably. Therefore, the vaginal anterior wallcan be spaced apart from the urethra more reliably, without beinginfluenced by the shape of the vagina. Particularly, for example, inthis embodiment, the insertion section 511 is flat shaped, so that thevaginal anterior wall can be suction held in the manner of being spacedfarther away from the urethra, and the biological tissue between theurethral wall and the vaginal wall can be widened more widely.

In addition, the insertion section 511 is provided with a marker(puncture position confirmation section) 57 with which the punctureroute of the puncture device 1 can be confirmed. In accordance with anexemplary embodiment, the puncture device can be fixed so as to puncturethe region between the vaginal wall, which is present on the uppersurface of the position where the marker 57 exists, and the urethralwall. As a result, the operability and safety of the insertion tool 6are enhanced. The marker 57 is provided at least on a lower surface 511b of the insertion section 511. The lower surface 511 b is a surfacewhich is oriented toward the vaginal orifice side and is visible by theoperator through the vaginal orifice, in the inserted state. With themarker 57 provided on the lower surface 511 b, therefore, the punctureroute of the puncture device 1 can be confirmed more reliably. Inaccordance with an exemplary embodiment, the depth of insertion of theinsertion section 511 into the vagina can also be confirmed. Note thatit is sufficient for the marker 57 to be visible externally, and themarker 57 can be configured as a colored part, a rugged part or thelike.

The non-insertion section 512 is in the shape of a thin bar extendingsubstantially in parallel to the urethral-insertion section 41. Thespacing D between the non-insertion section 512 and theurethral-insertion section 41 is not particularly limited, and ispreferably about 10 to 40 mm, correspondingly to the spacing between theurethral orifice and the vaginal orifice in general women.

The length of the non-insertion section 512 (the spacing between thevaginal orifice and the support section 50) is not specificallyrestricted, and is preferably not more than about 100 mm, morepreferably in the range of about 20 to 50 mm. By this, the non-insertionsection 512 can be made to have a suitable length, and its operabilityis enhanced. If the length of the non-insertion section 512 exceeds theabove-mentioned upper limit, there may arise, depending on theconfiguration of the frame 2 or the like, a situation in which thecenter of gravity of the puncture device 1 is largely spaced from thepatient and, accordingly, the stability of the puncture device 1 in themounted state is lowered.

The support section 50 is provided with a male screw 501. With the malescrew 501 fastened into a female screw (not illustrated) provided in thesupport section 40, the support sections 40 and 50 are fixed to eachother.

The material constituting the vaginal-insertion member 5 is notspecifically restricted. In this case, there can be used, for example,various metallic materials such as stainless steel, aluminum or aluminumalloys, titanium or titanium alloys, and various resin materials, likein the case of the urethral-insertion member 4.

The configuration of the puncture device 1 has thus been describedabove.

Note that while the urethral-insertion member 4 and thevaginal-insertion member 5 constituting the insertion tool 6 have beenconfigured to be attachable to and detachable from each other in thepuncture device 1, this configuration is not restrictive. Theurethral-insertion member 4 and the vaginal-insertion member 5 may be soconfigured that they cannot be attached to or detached from each other.

In addition, while the urethral-insertion section 41 is fixed relativeto the support section 40 in the puncture device 1, this configurationis not restrictive. A configuration may be adopted wherein a state wherethe urethral-insertion section 41 is fixed relative to the supportsection 40 and a state where the urethral-insertion section 41 isslidable in the axial direction relative to the support section 40 canbe selected. Specifically, for example, a configuration may be adoptedwherein loosening a screw provided on the support section 40 results ina state where the urethral-insertion section 41 is slidable relative tothe support section 40 and wherein fastening the screw results in astate where the urethral-insertion section 41 is fixed relative to thesupport section 40. According to this configuration, the length of thenon-insertion section 412 can be adjusted, so that a user-friendlyinsertion tool 6 is realized. Note that the same applies to thevaginal-insertion section 51.

In accordance with an exemplary embodiment, while the component membersare fixed to the frame 2 so that the inclination angle θ2 is constant inthe puncture device 1, this configuration is not restrictive, and theinclination angle θ2 may be variable. Where the inclination angle θ2 isvariable, the inclination angle θ2 can be adjusted according to thepatient, so that a user-friendly puncture device 1 is realized.

A method of using the puncture device 1 will be described below. Priorto the description of the using method, the implant 9 to be used withthe puncture device 1 will be described.

An implant (biological tissue-supporting indwelling article) 9 shown inFIG. 18 is an embeddable instrument for treatment of female urinaryincontinence, for example, an instrument for supporting the urethra. Forexample, the implant 9 is an instrument, which, when the urethra isgoing to move toward the vaginal wall side, supports the urethra so asto restrict its movement in the direction for coming away from thevaginal wall. As the implant 9, for example, a flexible elongated bodycan be used.

The implant 9 can include the implant main body 91, and a bag-shapedwrapping material 92 for accommodating the implant main body 91. Inaddition, the implant main body 91 can include the main body section911, and a ribbon 912 interlocked to one end of the main body section911. With the implant 9 provided with the wrapping material 92,contamination of the implant main body 91 can be prevented effectively.Note that a guide wire, a cord, or a string may be used in place of theribbon 912.

The main body section 911 is net-like in form, and is belt-like inoverall shape. Note that the main body section 911 may be composed, forexample, of a network-like knitted body knitted by causing linearelements to intersect, for example, network-formed braiding. Examples ofthe linear element include those, which are circular in cross section,and those which are flat shaped in cross section, for example,belt-shaped (ribbon-shaped) ones.

The materials constituting the main body section 911, the ribbon 912 andthe wrapping material 92 are not particularly limited. For example,various resin materials which are biocompatible such as polypropylene,polyesters, nylon, and fibers can be used as the materials.

Note that the implant 9 is not limited to the above-mentionednetwork-formed one, so long as the same or equivalent effect can beexhibited.

An operating procedure of the puncture device 1, for example, aprocedure for embedding the implant 9 into a living body will bedescribed.

First, a patient is placed in a lithotomy position on an operatingtable, and the insertion tool 6 is mounted onto the patient, as depictedin FIG. 19(a). For example, first, the urethral-insertion section 41 ofthe urethral-insertion member 4 is inserted into the patient's urethra1300. In this case, the depth of insertion is confirmed with the marker46, and the balloon 42 is disposed inside the bladder 1310. The urethra1300 is corrected into a predetermined shape by the urethral-insertionsection 41 having the predetermined shape. In the case of thisembodiment, the urethra is corrected into a rectilinear shape by theurethral-insertion section 41, which is rectilinear in shape.

Next, the balloon 42 is expanded, and urine is drained from within thebladder 1310 via the drain hole 471, as required. In accordance with anexemplary embodiment, the vaginal-insertion section 51 of thevaginal-insertion member 5 is inserted into the patient's vagina 1400.In this case, the puncture position is confirmed with the marker 57, andinsertion into a suitable depth is performed. Then, the support sections40 and 50 are fixed by operating the male screw 501. By this, themounting of the insertion tool 6 onto the patient is completed. In thisstate, the non-insertion sections 412 and 512 are spaced apart from eachother, and, further, the support section 60 is spaced apart from a bodysurface between the urethral orifice and the vaginal orifice, so thatthe body surface is exposed. In addition, in the case where theinsertion section 511 and the vaginal anterior wall are spaced apartfrom each other to form a gap (space) therebetween, there is formed aspace S3 for permitting a syringe to puncture the biological tissuebetween the urethra and the vagina via the body surface between theurethral orifice and the vaginal orifice.

Subsequently, suction devices are connected to the suction ports 45 and54, and the suction devices are operated, to suction hold the urethralposterior wall onto the urethral-insertion section 41 and suction holdthe vaginal anterior wall onto the vaginal-insertion section 51. Forexample, when the urethral posterior wall is suction held onto theurethral-insertion section 41 properly, the suction holes 44 are closedwith the urethral wall, so that the suction via the suction port 45 isstopped or weakened. Similarly, when the vaginal anterior wall issuction held onto the vaginal-insertion section 51 properly, the suctionholes 59 are closed with the vaginal wall, so that the suction via thesuction port 54 is stopped or weakened. Therefore, on the basis of themanners of suction via the suction ports 45 and 54 (for example, on thebasis of the magnitudes of the sounds generated upon the suction), theoperator can check whether or not the urethral posterior wall and thevaginal anterior wall are suction held onto the urethral-insertionsection 41 and the vaginal-insertion section 51 properly. Note that theinsertion tool 6 may be provided with a checking mechanism formechanically checking the suction-held state. The checking mechanism isnot specifically restricted, so long as the suction-held state can bechecked by use of the mechanism. For example, there may be adopted aconfiguration including a flow rate measuring section (negative pressuremeter) for measuring the flow rate through the suction port 54, and adetermining section for determining whether or not the suction holdingis performed properly, on the basis of the measurement results suppliedfrom the flow rate measuring section.

Next, liquid dissection is conducted. For example, as shown in FIG.19(b), a puncture needle of a syringe 2000 is made to puncture thevaginal anterior wall 1410 through the space (space S3) between theinsertion section 511 and the vaginal anterior wall 1410, and a liquidsuch as physiological saline or local anesthetic is injected into thebiological tissue in a region between the urethra 1300 and the vagina1400 (a region between the region S1 and the region S2). As a result,the biological tissue between the regions S1 and S2 is expanded, theurethral posterior wall is pressed against the urethral-insertionsection 41, and the vaginal anterior wall is pressed against thevaginal-insertion section 51.

Here, it is preferable to continue the suction via the suction holes 44and 59 even during the liquid dissection. When the urethral posteriorwall is pressed against the urethral-insertion section 41 by the liquiddissection, the urethral posterior wall is suction held onto theurethral-insertion section 41 more securely, so that the suction throughthe suction port 45 is stopped or weakened. Similarly, when the vaginalanterior wall is pressed against the vaginal-insertion section 51, thevaginal anterior wall is suction held onto the vaginal-insertion section51 more securely, so that the suction through the suction port 45 isstopped or weakened. Therefore, on the basis of the manners of suctionvia the suction ports 45 and 54, the operator can check whether or notthe liquid dissection is performed properly.

After the liquid dissection is performed and the urethral posterior walland the vaginal anterior wall are sufficiently spaced apart, the frame 2is fixed to the insertion tool 6, as shown in FIG. 20. This results in astate in which the puncture device 1 is mounted onto the patient. Inthis state, the positional relation between the pelvis 1100 and thepuncture device 1 is as depicted in FIG. 21.

Subsequently, for example, while gripping the interlock section 23 ofthe frame 2 by one hand, the interlock section 72 of the operatingmember 7 is grasped by the other hand, and, as shown in FIG. 22(a), theoperating member 7 is rotated counterclockwise, which causes the needlebody 35 of the puncture member 3 to puncture a body surface H at a part(first part) in an inguinal region on the right side of the patient ornear the inguinal region, thereby entering the body, to sequentiallypass an obturator foramen 1101 on one side, between the urethra 1300 andthe vagina 1400, and an obturator foramen 1102 on the other side, thento exit the body via the body surface H at a part (second part) in aninguinal region on the left side or near this inguinal region, andfinally to evacuate into the guide section 22 (see FIG. 23).

As a result, the puncture member 3 is disposed in the living body, and,by the aforementioned principle, the anchors 81 and 82 are engaged withthe main body 31. Therefore, the anchor 82 abuts on the body surface H,whereby further insertion of a proximal portion of the main body 31 intothe living body is restrained. In accordance with an exemplaryembodiment, the state where the proximal end of the main body 31 isexposed outside of the living body can be secured.

Next, the operating member 7 is rotated clockwise in FIG. 22(a). In thiscase, although the puncture member 3 also tends to rotate clockwisetogether with the operating member 7, the abutment of the anchor 81against the body surface H prevents further rotation (movement) of thepuncture member 3. Therefore, while the state where the distal end ofthe main body 31 is exposed outside of the living body is maintained,the insertion section 71 is drawn out of the puncture member 3 and theliving body. Subsequently, the puncture device 1 (other members than thepuncture member 3) is dismounted from the patient, and, further, theneedle body 35 is detached from the main body 31, which results in astate in which only the main body 31 is disposed inside the living body,as shown in FIG. 22(b). The main body 31 is disposed inside the livingbody, with both the distal-side opening and the proximal-side openingexposed outside of the living body.

Subsequently, the position of the main body 31 is adjusted, as required.Specifically, the main body 31 is shifted toward the proximal side orthe distal side so that the positions of the anchors 81 and 82 relativeto the living body will be in left-right symmetry. By this, the centralportion S4 of the main body 31 can be positioned between the urethra1300 and the vagina 1400 more reliably. In this state, as shown in FIG.24, the central portion S4 is so disposed that its width direction (themajor axis direction of the cross section) W is substantially parallelto the urethra 1300. The urethra 1300 corrected in shape by theinsertion of the urethral-insertion member 4 therein and the widthdirection W of the central portion S4 are substantially parallel to eachother.

Next, while taking the implant main body 91 out of the wrapping material92, the implant main body 91 is inserted into the main body 31, and astate where the ribbon 912 is protruded from the proximal-side openingand the distal-side opening of the main body 31 is established, as shownin FIG. 25(a). Thus, the implant main body 91 is kept accommodatedinside the wrapping material 92 until immediately before disposed insidethe main body 31, whereby contamination of the implant main body 91 canbe prevented. Note that, as described above, since the main body 31 isflat shaped, the posture of the main body section 911 follows this flatshape. For example, as shown in FIG. 25(b), the main body section 911 isdisposed inside the main body 31 in such a manner that its widthdirection coincides with the width direction of the main body 31. As forthe relation with the urethra 1300, the implant main body 91 is disposedin parallel to the urethra 1300, which has been corrected in shape.

Subsequently, as shown in FIG. 26(a), the string 341 exposed from theexposure holes 345 and 346 is cut, which results in a state in which themain body 31 can be separated into the distal separable piece 32 and theproximal separable piece 33. Note that the exposure holes 345 and 346are located on the proximal side as compared with the anchor 82 and,therefore, can be exposed outside of the living body. Accordingly, thecutting of the string 341 can be carried out relatively easily.

Next, the suction holding of the urethral posterior wall by theurethral-insertion section 41 and the suction holding of the vaginalanterior wall 1410 by the vaginal-insertion section 51 are stopped. As aresult, the positions and shapes of the urethra 1300 and the vagina 1400are returned into the original natural states.

Subsequently, the connection between the distal separable piece 32 andthe proximal separable piece 33 is released, the distal separable piece32 is drawn out of the living body toward the distal side, and theproximal separable piece 33 is drawn out of the living body toward theproximal side. In this case, the distal separable piece 32 and theproximal separable piece 33 are substantially simultaneously moved inopposite directions, and the distal separable piece 32 and the proximalseparable piece 33 are moved in circular arc courses along their shapes,respectively. By this, the main body 31 is smoothly removed out of theliving body. As the distal separable piece 32 and the proximal separablepiece 33 are gradually removed out of the living body as aforementioned,the surrounding tissue having been pushed open by the main body 31returns into its original position, and the tissue comes into contactwith the implant main body 91 gradually from a central portion towardboth end portions of the implant main body 91. As aforementioned, thedistal separable piece 32 and the proximal separable piece 33 are movedin the directions along their shapes, and the main body 31 is providedwith the internal space in which the implant main body 91 can be movedwith sufficiently low friction. This enables the implant main body 91 tobe left indwelling as it is, without any unnecessary tension exertedthereon. As a result, it is unnecessary to adjust a tension on theimplant main body 91. The above operations result in a state in whichthe implant main body 91 is embedded in the living body, as shown inFIG. 26(b).

In the state where the implant main body 91 is embedded inside theliving body, the main body section 911 is disposed substantially inparallel to the urethra 1300, in a region between the urethra 1300 andthe vagina 1400. Therefore, the urethra 1300 can be supported in a widerarea by the implant main body 91.

Thus, by removing the main body 31 out of the living body throughdividing the main body 31, the main body 31 can be relatively easilydrawn out of the living body. In addition, since the main body 31 can bedrawn out of the living body without need to remove the anchors 81 and82 from the main body 31, the main body 31 can be drawn out easily. Inaccordance with an exemplary embodiment, according to such a drawing-outmethod, the separable pieces 32 and 33 being drawn out exert littleinfluence on the posture of the main body section 911 in the regionbetween the urethra 1300 and the vagina 1400.

Next, the suction holding of the urethral anterior wall by theurethral-insertion member 4 is stopped, followed by drawing theurethral-insertion member 4 out of the urethra 1300. After theurethral-insertion member 4 is drawn out, the urethra 1300 returns intoits shape in the natural state. Since the main body section 911 isembedded in the tissue, however, a state in which the urethra 1300 inthe natural state and the main body section 911 are parallel can bemaintained.

Thereafter, unnecessary portions of the implant main body 91 can be cutaway, to finish the procedure.

As has been described above, according to the puncture device 1,placement of the implant 9 indwelling can be dealt with by onlylow-invasive procedures such as puncture by the puncture member 3, andwithout need for high-invasive procedures such as incision. Therefore,the burden on the patient is light, and the safety of the patient ishigh. In addition, since the implant main body 91 can be embedded inparallel to the urethra 1300, the urethra 1300 can be supported in awider area. In accordance with an exemplary embodiment, the living bodycan be punctured by the puncture member 3 while avoiding the urethra1300 and the vagina 1400, so that puncture of the urethra 1300 or thevagina 1400 with the puncture member 3 can be prevented from occurring,and safety is therefore relatively ensured. Further, unlike in the caseof conventional incision of the vagina, a situation can be avoided inwhich the implant 9 would be exposed to the inside of the vagina via awound caused by the incision, or a situation in which complicationswould be generated such as infection from the wound. Thus, relativelyhigh safety can be ensured, and the implant 9 can be reliably embedded.

Referring to FIGS. 27 and 28, the second embodiment of a puncture devicewill be described below. The following description will center ondifferences from the aforementioned embodiment, and descriptions of thesame items as above will be omitted.

This embodiment is the same as the aforementioned first embodiment,except mainly for differences in the configuration of puncture member.

As shown in FIG. 27, a puncture member 3A in this embodiment is composedof a sheath 30. In accordance with an exemplary embodiment, the puncturemember 3A is configured by omitting the needle body 35 from the puncturemember 3A in the aforementioned first embodiment. In addition, in astate (initial state) where an insertion section 71 is inserted in thepuncture member 3A, a distal portion 711 as a distal portion of theinsertion section 71 is protruding from a distal-side opening of a mainbody 31. The distal portion 711 protruding from the main body 31 canfunction as a needle tip of the puncture member 3A. With the distalportion 711 of the insertion section 71 thus functioning also as theneedle body of the puncture member 3A, the number of members can bereduced, as compared with the aforementioned first embodiment, forexample. In accordance with an exemplary embodiment, when the puncturemember 3A is made to puncture a living body and the insertion section 71is drawn out of the puncture member 3, the distal-side opening of themain body 31 can be opened. In accordance with an exemplary embodiment,unlike in the aforementioned first embodiment, the needle body 35 doesnot need to be detached in order to open the distal-side opening of themain body 31, and, accordingly, the operation can be carried outsmoothly. In addition, the outside diameter of the insertion section 71and the inside diameter of the distal-side opening of the main body 31can be set to be substantially the same, so that slippage of theinsertion section 71 relative to the main body 31 can be prevented and,hence, operability is enhanced.

In accordance with an exemplary embodiment, the main body 31 is providedat its distal portion with a tapered section 319 where its outsidediameter gradually increases along the proximal direction from itsdistal-side opening. The tapered section 319 functions as a dissectingsection which, as the distal portion 711 of the insertion section 71punctures a living body, dissects the living body in the manner ofgradually expanding the living body, following the distal portion 711.

Note that while the taper angle of the tapered section 319 and the taperangle of the distal portion 711 may be the same, they are preferablydifferent from each other as shown in FIG. 27. In this case, it ispreferable that the taper angle of the tapered section 319 is smallerthan the taper angle of the distal portion 711. This configurationenables smooth puncture.

According to the second embodiment as above, also, the same orequivalent effects to those of the aforementioned first embodiment canbe produced.

In addition, as a modification of this embodiment, the followingconfiguration may be mentioned. As shown in FIG. 28, a puncture member3A is composed of a sheath 30. In accordance with an exemplaryembodiment, the puncture member 3A is configured by omitting the needlebody 35 from the puncture member 3A in the aforementioned firstembodiment. In accordance with an exemplary embodiment, in a state(initial state) where an insertion section 71 is inserted in thepuncture member 3, a distal portion 711 as a distal portion of theinsertion section 71 is protruding from a distal-side opening of a mainbody 31.

The distal portion 711 is provided in a detachable manner in relation tothe insertion section 71, through screw engagement, fitting or the like.In addition, the distal portion 711 has a needle tip 712 protruding fromthe distal end of the sheath 30. The needle tip 712 has a flat shapemodeled after the sheath 30. In accordance with an exemplary embodiment,the needle tip 712 can include a gradually increasing area section 712 awhere its cross-sectional area gradually increases toward its distalend; and a gradually decreasing area section 712 b which is provided onthe distal side of the gradually increasing area section 712 a and inwhich its cross-sectional area gradually decreases toward its distalend. The minor axis of a boundary 712 c between the gradually increasingarea section 712 a and the gradually decreasing area section 712 b islonger than the minor axis at the distal end of the sheath 30, and themajor axis of the boundary 712 c is longer than the major axis at thedistal end of the sheath 30, which can help ensure that the inside of aliving body can be punctured substantially by only the needle tip 712.Therefore, puncture resistance can be reduced, and a living body can bepunctured smoothly. Note that the minor axis of the boundary 712 c maybe equal to the minor axis at the distal end of the sheath 30, and themajor axis of the boundary 712 c may be equal to the major axis at thedistal end of the sheath 30.

Referring to FIG. 29, the third embodiment of a puncture device will bedescribed below. The following description will center on differencesfrom the aforementioned embodiments, and descriptions of the same itemsas above will be omitted.

This embodiment is the same as the aforementioned first embodiment,except mainly for differences in the configuration of puncture member.

As shown in FIG. 29, a main body 31 of a puncture member 3B has aconfiguration wherein a distal separable piece 32 and a proximalseparable piece 33 are connected with each other through a brittlesection 36. In this embodiment, the distal separable piece 32, theproximal separable piece 33 and the brittle section 36 are formedintegrally. The configuration of the brittle section 36 is notparticularly limited, so long as the brittle section 36 is more brittleand easier to break than the distal separable piece 32 and the proximalseparable piece 33. For example, the brittle section 36 may beconfigured to have perforations 361 provided along the entirecircumference of the main body 31.

For instance, when the distal separable piece 32 grasped by one hand andthe proximal separable piece 33 grasped by the other hand are pulledaway from each other, the brittle section 36 is broken, and the distalseparable piece 32 and the proximal separable piece 33 are separatedfrom each other. According to such a configuration, the overlapping ofthe distal separable piece 32 and the proximal separable piece 33 witheach other as in the aforementioned first embodiment can be avoided.Therefore, no step is generated at the boundary between the distalseparable piece 32 and the proximal separable piece 33, so that punctureby the puncture member 3B and insertion and passage of an implant mainbody 91 into and through the main body 31 can be performed smoothly. Inaddition, since the brittle section 36 can function as a statemaintaining mechanism for maintaining the connected state of the distalseparable piece 32 and the proximal separable piece 33, the statemaintaining mechanism 34 as in the aforementioned first embodiment canbe omitted. Consequently, the configuration of the puncture member 3Bcan be simplified.

According to the third embodiment as above, also, the same or equivalenteffects to those of the aforementioned first embodiment can be produced.

Referring to FIG. 30, the fourth embodiment of a puncture device will bedescribed below. The following description will center on differencesfrom the aforementioned embodiments, and descriptions of the same itemsas above will be omitted.

This embodiment is the same as the aforementioned first embodiment,except mainly for differences in the configuration of puncture member.

As shown in FIG. 30, a state maintaining mechanism 34C possessed by apuncture member 3C in this embodiment further can include holes 342 dand 342 e and an endless string (connecting member) 349 inserted in andpassed through the holes 342 d and 342 e, in addition to the statemaintaining mechanism 34 in the aforementioned first embodiment.

The hole 342 d is provided in a distal portion of a proximal separablepiece 33, at a position near an inner circumferential portion A1 of afront surface A3. In accordance with an exemplary embodiment, the hole342 e is provided in a proximal portion of a distal separable piece 32,at a position near an outer circumferential portion A2 of the frontsurface A3.

The string 349 is mostly disposed inside a main body 31, and is exposedoutside of the main body 31 between the hole 342 d and the hole 342 eand between a hole 342 a and a proximal-side opening 332. The string 349can be obtained, for example, by preparing a string having ends,inserting one end of the string into the main body 31 via theproximal-side opening 332, leading the one end out of the main body 31via the hole 342 d, inserting the one end into the main body 31 via thehole 342 e, leading the one end out of the main body 31 via the hole 342a, and finally tying the one end with the other end of the string in thevicinity of the proximal-side opening 332. It is to be noted, however,that the position of the knot is not specifically restricted.

In addition, like the string 341, the string 349 is exposed outside ofthe main body 31 via exposure holes 345 and 346. Like the string 341,therefore, the string 349 can be cut by way of the exposure holes 345and 346. With the string 349 laid around in this manner, the followingeffects can be produced. That is, in the aforementioned firstembodiment, the holes 342 a, 342 b and 342 c are all formed at positionsnear the inner circumferential portion A1, and the string 341 is alsolaid around near the inner circumferential portion A1. Therefore, acontracting force is exerted on the inner circumferential portion A1side, and the main body 31 may be deformed so that those portions of theseparable pieces 32 and 33 which are located on the outercircumferential portion A2 side are spaced away from each other. Uponsuch a deformation, a gap or a large step may be formed at the boundarybetween the separable pieces 32 and 33, possibly influencing thepuncture of a living body. In view of this problem, in this embodiment,the hole 342 d near the inner circumferential portion A1 of the proximalseparable piece 33 and the hole 342 e near the outer circumferentialportion A2 of the distal separable piece 32 are formed, and the string349 is laid around through these holes. As a result, such a deformationas aforementioned can be inhibited, and the main body 31 can bemaintained in a predetermined shape.

According to the fourth embodiment as above, also, the same orequivalent effects to those of the aforementioned first embodiment canbe produced.

Note that while the two strings 341 and 349 are used in the statemaintaining mechanism 34C in this embodiment, these strings may beintegrated into one (string 341). In this case, the string 341 can beobtained, for example, by inserting one end of a string (which has ends)into the main body 31 via the proximal-side opening 332, leading the oneend out of the main body 31 via the hole 342 d, inserting the one endinto the main body 31 via the hole 342 e, leading the one end out of themain body 31 via the hole 342 b, inserting the one end into the mainbody 31 via the hole 342 c, leading the one end out of the main body 31via the hole 342 a, and finally tying the one end with the other end ofthe string in the vicinity of the proximal-side opening 332.

Referring to FIG. 31, the fifth embodiment of a puncture device will bedescribed below. The following description will center on differencesfrom the aforementioned embodiments, and descriptions of the same itemsas above will be omitted.

This embodiment is the same as the aforementioned first embodiment,except mainly for differences in the configuration of puncture member.

As shown in FIG. 31, a state maintaining mechanism 34D possessed by apuncture member 3G in this embodiment is configured by omitting the hole342 c from the state maintaining mechanism 34 in the aforementionedfirst embodiment, and using a string 341 which has ends. The string 341is disposed inside a main body 31. One end of the string 341 protrudesfrom a hole 342 a, and a knot 341 a is formed at the protruding portion.The knot 341 a is so sized as to be unable to pass through the hole 342a. In accordance with an exemplary embodiment, the other end of thestring 341 protrudes from a hole 342 b, and a knot 341 b is formed atthe protruding portion. The knot 341 b is so sized as to be unable topass through the hole 342 b. The state maintaining mechanism 34D has thestring 341 disposed in this manner, whereby a connected state of adistal separable piece 32 and a proximal separable piece 33 ismaintained.

According to the fifth embodiment as above, also, the same or equivalenteffects to those of the aforementioned first embodiment can be produced.

Referring to FIG. 32, the sixth embodiment of a puncture device will bedescribed below. The following description will center on differencesfrom the aforementioned embodiments, and descriptions of the same itemsas above will be omitted.

This embodiment is the same as the aforementioned first embodiment,except mainly for differences in the configuration of puncture member.

As shown in FIG. 32, a state maintaining mechanism 34E possessed by apuncture member 3E in this embodiment can include holes 342 f and 342 g,342 h and 342 i, and a wire (linear element) 39 which is elastic andpassed through the holes 342 f and 342 g, 342 h and 342 i.

The holes 342 f and 342 g are provided in a distal portion of an innercircumferential portion A1 of a proximal separable piece 33, juxtaposelyin the axial direction. The holes 342 h and 342 i are provided in aproximal portion of the inner circumferential portion A1 of a distalseparable piece 32, juxtaposely in the axial direction. In addition, theholes 342 f and 342 h are overlapping with each other, and the holes 342g and 342 i are overlapping with each other. The wire 39 is led out of amain body 31 via the holes 342 f and 342 h, and led into the main body31 via the holes 342 g and 342 i. By this, a connected state of theseparable pieces 32 and 33 is maintained. Note that in the statemaintaining mechanism 34E, drawing out the wire 39 via a proximal-sideopening of the main body 31 results in a state in which the separablepieces 32 and 33 can be separated apart.

The wire 39 is not particularly limited. For example, wires formed ofvarious metallic materials such as stainless steel, cobalt alloys,nickel alloys, etc. and wires composed of piano wire can be used as thewire 39.

According to the sixth embodiment as above, also, the same or equivalenteffects to those of the aforementioned first embodiment can be produced.

Referring to FIGS. 33(a)-33(c), the seventh embodiment of a puncturedevice will be described below. Note that in FIGS. 33(a)-33(c), forconvenience of explanation, a puncture member extending in a circulararc shape is depicted in the state of being stretched rectilinearly. Thefollowing description will center on differences from the aforementionedembodiments, and descriptions of the same items as above will beomitted.

This embodiment is the same as the aforementioned first embodiment,except mainly for differences in the configuration of puncture member.

As shown in FIGS. 33(a)-33(c), a state maintaining mechanism 34Fpossessed by a puncture member 3F in this embodiment can include a hole342 a, a hole 352 a provided in a proximal section 352 of a needle body35, and a string 341. The string 341 is disposed inside a main body 31,is passed through the hole 352 a to be thereby engaged with the needlebody 35, and is passed through the hole 342 a to be thereby engaged witha proximal separable piece 33. This configuration ensures that a statewhere a distal separable piece 32 is clamped between the proximalseparable piece 33 and the needle body 35 can be maintained, so that aconnected state of the separable pieces 32 and 33 can be maintained.Note that in the state maintaining mechanism 34F, cutting the string 341results in a state where the separable pieces 32 and 33 can be separatedapart from each other.

Note that the string 341 can be obtained, for example, by preparing astring which has ends, inserting one end of the string into the mainbody 31 via a proximal-side opening 332, passing the one end through thehole 352 a, leading the one end out of the main body 31 via the hole 342a, and finally tying the one end with the other end of the string in thevicinity of the proximal-side opening 332.

According to the seventh embodiment as above, also, the same orequivalent effects to those of the aforementioned first embodiment canbe produced.

Referring to FIGS. 34 and 35, the eighth embodiment of a puncture devicewill be described below. The following description will center ondifferences from the aforementioned embodiments, and descriptions of thesame items as above will be omitted.

This embodiment is the same as the aforementioned first embodiment,except mainly for differences in the configuration of puncture member.

As shown in FIG. 34, a state maintaining mechanism 34G possessed by apuncture member 3G in this embodiment can include holes 342 j and 342 kprovided in a distal separable piece 32; projections 343 a and 343 bprovided as parts of a proximal separable piece 33; and a stylet(tubular body) 344 inserted in a main body 31. The holes 342 j and 342 kare separately formed in a front surface A3 and a back surface A4 of aproximal portion of the distal separable piece 32. In accordance with anexemplary embodiment, the projections 343 a and 343 b are separatelyprovided as parts of the front surface A3 and the back surface A4 of adistal portion of the proximal separable piece 33. The projection 343 ais in engagement with the hole 342 j, and the projection 343 b is inengagement with the hole 342 k. In addition, the stylet 344 is insertedin the main body 31, and inward displacement of the projections 343 aand 343 b is restrained by the stylet 344. This configuration also canhelp ensure that a connected state of the separable pieces 32 and 33 canbe maintained. Note that in the state maintaining mechanism 34G, drawingthe stylet 344 out of the main body 31 to establish a state where theprojections 343 a and 343 b can be displaced inward results in a statein which the separable pieces 32 and 33 can be separated apart from eachother.

The material constituting the stylet 344 is preferably a rigid materialsuch that displacement of the projections 343 a and 343 b can berestrained thereby. Examples of the rigid material usable includevarious resin materials such as polyethylene, polyimides, polyamides,polyester elastomers, polypropylene, etc. and various metallic materialssuch as stainless steel, aluminum or aluminum alloys, titanium ortitanium alloys, etc. Note that the configuration of the stylet 344 canbe achieved not only by the adoption of the rigid material but also byadopting other material than rigid material and reinforcing a wall ofthe stylet with a reinforcement member.

According to the eighth embodiment as above, also, the same orequivalent effects to those of the aforementioned first embodiment canbe produced.

Note that while the state maintaining mechanism 34G has the stylet 344in this embodiment, a configuration may be adopted in which an insertionsection 71 inserted in the main body 31 functions also as a stylet 344as shown in FIG. 35. In accordance with an exemplary embodiment, aconfiguration may be adopted in which inward displacement of theprojections 343 a and 343 b is restrained by the insertion section 71.

Referring to FIGS. 36(a)-36(c), the ninth embodiment of a puncturedevice will be described below. Note that in FIGS. 36(a)-36(c), forconvenience of explanation, a puncture member extending in a circulararc shape is depicted in the state of being stretched rectilinearly. Thefollowing description will center on differences from the aforementionedembodiments, and descriptions of the same items as above will beomitted.

This embodiment is the same as the aforementioned first embodiment,except mainly for differences in the configuration of puncture member.

As shown in FIGS. 36(a)-36(c), a state maintaining mechanism 34Hpossessed by a puncture member 3H in this embodiment can include a hole342 l provided in a distal separable piece 32, and an elastic wire 38.The wire 38 is provided at a distal portion thereof with a distal hook(claw section) 381 hooked on the hole 342 l, and is provided at aproximal portion with a proximal hook (claw section) 382 hooked on theproximal end of a proximal separable piece 33. With the distal hook 381and the proximal hook 382 hooked respectively on the hole 342 l and theproximal separable piece 33, a connected state of the separable pieces32 and 33 can be maintained. Note that in the state maintainingmechanism 34H, pushing in the wire 38 toward the distal side to evacuatethe distal hook 381 into a main body 31 and thereby disengaging thedistal hook 381 and the hole 342 l from each other results in a state inwhich the separable pieces 32 and 33 can be separated apart from eachother.

According to the ninth embodiment as above, also, the same or equivalenteffects to those of the aforementioned first embodiment can be produced.

While the medical tube and medical tube assembly of the presentdisclosure have been described above on the basis of the illustratedembodiments, the present disclosure is not limited to the embodiments.The configuration of each component can be replaced with an arbitraryconfiguration having the same or equivalent function. In accordance withan exemplary embodiment, other arbitrary structure or structures may beadded to the present disclosure.

In addition, while the needle body is retained on the main body in anattachable and detachable manner in the above embodiments, thisconfiguration is not restrictive. For example, the needle body may befixed to the main body, like in a configuration wherein the main bodyand the needle body are formed integrally. In this case, the distal-sideopening of the main body can be opened by cutting the needle body by useof a pair of scissors or the like, after a living body is punctured bythe puncture member and the needle body is protruded to the outside ofthe living body.

In addition, while the sheath is configured as part of the puncturemember in the above embodiments, this configuration is not restrictive.For example, a sheath may be used in the manner of being inserted into apenetrating hole preliminarily formed in a living body by use of somemeans. The method for forming the penetrating hole inside the livingbody is not particularly limited. There can be used, for example, adevice configured as if obtained by omitting the puncture member fromthe aforementioned puncture device. In this case, the insertion sectionfunctions as a puncture member.

In accordance with an exemplary embodiment, while a case where thepuncture device is applied to a device for use in embedding in a livingbody an embeddable implant for treatment of female urinary incontinencehas been described in the above embodiments, the use of the puncturedevice is not limited to the described one.

For example, the target of the application of the present disclosure caninclude excretory disorders as a result of the weakening of the pelvicfloor muscle group (urinary urgency, frequent urination, urinaryincontinence, fecal incontinence, urinary retention, or dysuria), andpelvic floor disorders including pelvic organ prolapse, vesicovaginalfistula, urethrovaginal fistula, pelvic pain or the like. In the pelvicorgan prolapse, there are included disorders of cystocele, enterocele,rectocele, uterine prolapse and the like. Alternatively, there areincluded such disorders as anterior vaginal prolapse, posterior vaginalprolapse, vaginal apical prolapse, vaginal vault prolapse and the likein which the naming method thereof is based on the prolapsedvaginal-wall part.

Also, overactive tissues include bladder, vagina, uterus, bowel and thelike. Lessactive tissues include bones, muscles, fascias, and ligaments.In accordance with an exemplary embodiment, in the case of pelvic floordisorders, the lessactive tissues include an obturator fascia, acoccygeus fascia, a cardinal ligament, an uterosacral ligament, and asacrospinous ligament.

For the procedure for interlocking an overactive tissue in the pelvicfloor disorder with the lessactive tissue, there are included aretropubic sling surgery, a transobturator sling surgery (transobturatortape (TOT) surgery), a tension-free vaginal mesh (TVM) surgery, auterosacral ligament suspension (USLS) surgery, a sacrospinous ligamentfixation (SSLF) surgery, an iliococcygeus fascia fixation surgery, and acoccygeus fascia fixation surgery.

The medical tube of the present disclosure is a medical tube to be usedin introducing into a living body a belt-shaped elongated article fortreatment of a pelvic organ. The medical tube can include a main body inwhich a distal portion of a tubular proximal separable piece isdetachably connected to a proximal portion of a tubular distal separablepiece; and a state maintaining mechanism for maintaining a connectedstate of the distal separable piece and the proximal separable piece.The medical tube is characterized in that the main body is inserted intothe body starting from the distal separable piece side, and is disposedinside the body in a state in which the distal end and the proximal endthereof are exposed outside of the living body. Therefore, the main bodycan be disposed inside the body while maintaining the connected state ofthe distal separable piece and the proximal separable piece, and themain body can be smoothly disposed into the body. At the time of drawingthe main body out of the body, In accordance with an exemplaryembodiment, the state maintaining mechanism is released, whereby thedistal separable piece can be drawn out from the distal side, and theproximal separable piece can be drawn out from the proximal side. Thus,by drawing out the main body through dividing the main body into twopieces, the main body can be drawn out of the body easily. In addition,the main body can be drawn out of the body while maintaining the postureof the implant disposed inside the main body.

Accordingly, the medical tube of the present disclosure has industrialapplicability.

The detailed description above describes a medical tube and a medicaltube assembly. The invention is not limited, however, to the preciseembodiments and variations described. Various changes, modifications andequivalents can be effected by one skilled in the art without departingfrom the spirit and scope of the invention as defined in theaccompanying claims. It is expressly intended that all such changes,modifications and equivalents which fall within the scope of the claimsare embraced by the claims.

What is claimed is:
 1. A medical tube to be used in introducing into aliving body a belt-shaped elongated article for treatment of a pelvicorgan, the medical tube comprising: a main body in which a distalportion of a tubular proximal separable piece is detachably connected toa proximal portion of a tubular distal separable piece; and a statemaintaining mechanism maintaining a connected state of the distalseparable piece and the proximal separable piece, the state maintainingmechanism having an interlock member, which is disposed within the mainbody and interlocks the distal separable piece and the proximalseparable piece, and wherein the interlock member is a string, which isinserted into and passed through two or more holes in the proximalportion of the distal separable piece and at least one hole in aproximal portion of the proximal separable piece.
 2. The medical tubeaccording to claim 1, wherein the main body has a section curved in acircular arc shape.
 3. The medical tube according to claim 1, whereinthe main body is tubular in shape and has an internal space soconfigured that the belt-shaped elongated article can be inserted in theinternal space and passed through the internal space.
 4. The medicaltube according to claim 1, wherein the main body has a flat shape as across-sectional shape at least at a central portion in a longitudinaldirection of the main body.
 5. A medical tube assembly comprising: themedical tube according to claim 4; and a urethral-insertion section,which is configured to be inserted into a urethra, wherein in a state inwhich the main body is disposed inside the living body, the centralportion is located between the urethral-insertion section and a vagina,and a major axis direction of the central portion is substantiallyparallel to the urethral-insertion section.
 6. The medical tubeaccording to claim 1, wherein the connected state is released by cuttingthe interlock member.
 7. The medical tube according to claim 1, whereinthe distal portion of the proximal separable piece is inserted in theproximal portion of the distal separable piece, whereby the distalseparable piece and the proximal separable piece are connected.
 8. Amedical tube assembly comprising: the medical tube according to claim 1;and an elongated insertion section, which is inserted into the mainbody, wherein the medical tube assembly is used in a state in which theinsertion section is inserted into the main body.
 9. The medical tubeaccording to claim 1, wherein the string is arranged on an outer portionof the main body between the two or more holes in the proximal portionof the distal separable piece.
 10. The medical tube according to claim9, wherein the main body has an inner circumferential portion located atan inner circumferential edge and having a minimum radius of curvatureand an outer circumferential portion located at an outer circumferentialedge and having a maximum radius of curvature, and wherein the two ormore holes in the proximal two or more holes in the proximal portion ofthe distal separable piece and the at least one hole in the proximalportion of the proximal separable piece are located near the innercircumferential portion.
 11. A medical tube comprising: a tubular mainbody having a curved section and provided with an internal space inwhich a belt-shaped elongated article for treatment of urinaryincontinence can be inserted, wherein the main body includes a distalportion of a tubular proximal separable piece, which is detachablyconnected to a proximal portion of a tubular distal separable piece; andan interlock member, which is disposed within the main body andinterlocks the tubular distal separable piece and the tubular proximalseparable piece, and wherein the interlock member is a string, which isinserted into and passed through two or more holes in the proximalportion of the tubular distal separable piece and at least one hole in aproximal portion of the tubular proximal separable piece.
 12. Themedical tube according to claim 11, wherein the string is arranged on anouter portion of the main body between the two or more holes in theproximal portion of the tubular distal separable piece.
 13. A method ofintroducing a belt-shaped elongated article for treatment of a pelvicorgan into a living body with a medical tube, the medical tube having amain body defined by a distal portion of a tubular proximal separablepiece detachably connected to a proximal portion of a tubular distalseparable piece, the medical tube further having a state maintainingmechanism maintaining a connected state of the distal separable pieceand the proximal separable piece, the state maintaining mechanism havingan interlock member, which is disposed within the main body andinterlocks the distal separable piece and the proximal separable piece,wherein the interlock member is a string, which is inserted into andpassed through two or more holes in the proximal portion of the distalseparable piece and at least one hole in a proximal portion of theproximal separable piece, wherein the method comprises: inserting themain body of the medical tube into the living body starting from thedistal separable piece side; and disposing the main body of the medicaltube inside the living body in a state in which a distal end and aproximal end of the main body are exposed outside of the living body.14. The method according to claim 13, wherein the main body has asection curved in a circular arc shape.
 15. The method according toclaim 14, wherein the main body is tubular in shape and has an internalspace; and the method further comprises: inserting the belt-shapedelongated article in the internal space and passing the belt-shapedelongated article through the internal space.
 16. The method accordingto claim 15, wherein the main body has a flat shape as a cross-sectionalshape at least at a central portion in a longitudinal direction of themain body.
 17. The method according to claim 16, comprising: inserting aurethral-insertion section into a urethra; and locating the centralportion between the urethral-insertion section and a vagina such thatthe main body is disposed inside the living body and a major axisdirection of the central portion is substantially parallel to theurethral-insertion section.
 18. The method according to claim 13,comprising: cutting the interlock member to release the connected state.19. The method according to claim 13, comprising: arranging the stringon an outer portion of the main body between the two or more holes inthe proximal portion of the distal separable piece.